Methods and apparatus for introducing tumescent fluid to body tissue

ABSTRACT

A catheter is usable to treat a hollow anatomical structure (HAS). The catheter comprises one or more shafts which extend away from a proximal end of the catheter toward a distal end thereof. The catheter further comprises an HAS constriction energy source located at or near the distal end of the catheter. The catheter further comprises at least one radially expandable transmural fluid delivery channel located in the catheter near the HAS constriction energy source.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Application No. 60/693,366, filed Jun. 22, 2005, titledMETHODS AND APPARATUS FOR INTRODUCING TUMESCENT FLUID TO BODY TISSUE;and of U.S. Provisional Application No. 60/701,538, filed Jul. 20, 2005,titled METHODS AND APPARATUS FOR INTRODUCING TUMESCENT FLUID TO BODYTISSUE, the entire contents of each of which are hereby incorporated byreference herein and made part of this specification.

BACKGROUND

1. Field of the Invention

Certain embodiments disclosed herein relate generally to a method andapparatus for delivering tumescent fluids to body tissue. The targetbody tissue may surround a hollow anatomical structure such as a vein.Certain disclosed embodiments also relate generally to a method andapparatus for applying energy to constrict and/or shrink a hollowanatomical structure such as a vein, and more particularly, a method andapparatus to conduct electrical current and/or heat to the wall of thehollow anatomical structure.

2. Description of the Related Art

In endoluminal treatments of hollow anatomical structures (HAS's) suchas varicose veins, a tumescent fluid is often applied to the tissue nearthe target HAS to partially constrict the walls thereof and place themin firm apposition with a therapeutic device in the HAS lumen. Thetumescent fluid is usually applied via a series of injections throughthe skin of the patient into the underlying tissue which surrounds theHAS.

SUMMARY

In certain embodiments, a catheter treats a hollow anatomical structure(HAS). The catheter further comprises one or more shafts which extendaway from a proximal end of the catheter toward a distal end thereof.The catheter further comprises an HAS constriction energy source locatedat or near the distal end of the catheter. The catheter furthercomprises at least one radially expandable transmural fluid deliverychannel located in the catheter near the HAS constriction energy source.

In certain embodiments, the constriction energy source of the cathetercomprises an electrically resistive heating element. In one embodiment,the resistive heating element of the catheter comprises a resistivecoil. In another embodiment, the resistive heating element is located onan outer surface of one of one or more shafts, and the outer surfaceincludes at least one port through which at least one fluid deliverychannel is extendable. In certain embodiments, the constriction energysource of the catheter comprises at least one electrode.

In certain embodiments, one or more catheter shafts comprises a firstshaft which carries at least one electrode, and a second shaft whichcarries at least one fluid delivery channel. In certain embodiments, thefirst and second shafts are coaxial. In one embodiment, at least oneelectrode of the catheter comprises a plurality of electrodes. The firstelectrode is spaced longitudinally from a second electrode along anouter surface of one of one or more catheter shafts.

In certain embodiments, the fluid delivery channel comprises at leastone needle. In one embodiment, the needle of the catheter has a sharptip and a fluid delivery port at or near the tip. In one embodiment, thefluid delivery channel of the catheter comprises at least oneperforating jet. In certain embodiments, the catheter further comprisessource of tumescent fluid which is in fluid communication with the fluiddelivery channel. In certain embodiments, one or more catheter shaftscomprise a plurality of shafts which are arranged coaxially. In oneembodiment, the first and second shafts are coaxial.

In certain embodiments, a catheter treats a hollow anatomical structure.The catheter further comprises a shaft which extends from a proximal endto a distal end thereof. The catheter further comprises a therapeuticenergy source located at or near a distal end of the shaft. Thetherapeutic energy source comprises at least one of an electrode and aresistive heating element. At least one fluid delivery channel islocated in the shaft. The channel has a delivery tip which is movablefrom a retracted position near a longitudinal axis of the shaft, to adeployed position farther from the longitudinal axis.

In certain embodiments, the therapeutic energy source comprises aplurality of electrodes. A first electrode is spaced longitudinallyalong the catheter from a second electrode. In one embodiment, the fluiddelivery channel comprises at least one needle. In another embodiment,the needle has a sharp tip and a fluid delivery port at or near the tip.In certain embodiments, the fluid delivery channel comprises at leastone perforating jet. In certain embodiments, the catheter furthercomprises a source of tumescent fluid which is in fluid communicationwith the fluid delivery channel.

In certain embodiments, a method treats a hollow anatomical structurewith a catheter having one or more shafts which extend away from aproximal end of the catheter toward a distal end thereof. The methodfurther comprises conducting a fluid, via a fluid delivery channel ofthe catheter, from a location within the hollow anatomical structure andwithin one of the shafts, to a tip of the channel which is locatedradially outward from one or more shafts. A therapeutic energy source ofthe catheter system passes energy into a wall of the hollow anatomicalstructure. The energy constricts the hollow anatomical structure.

In certain embodiments, passing energy comprises driving RF energythrough the wall of the hollow anatomical structure with at least oneelectrode of the catheter. In one embodiment, passing energy comprisesheating the wall of the hollow anatomical structure with at least oneheating element of the catheter system. In another embodiment,conducting the fluid comprises conducting the fluid through the wall ofthe hollow anatomical structure. In certain embodiments, the methodfurther comprises penetrating the wall of the hollow anatomicalstructure with the channel.

In certain embodiments, conducting the fluid comprises conductingtumescent fluid into tissue near the hollow anatomical structure andthereby initially constricting the hollow anatomical structure. In oneembodiment, passing energy comprises passing energy after the initialconstriction of the hollow anatomical structure. In another embodiments,after passing the energy, the method further comprises moving the energysource along the hollow anatomical structure to a first subsequenttreatment position, and conducting the fluid via the fluid deliverychannel into tissue adjacent the hollow anatomical structure near thefirst subsequent treatment position. In certain embodiments, the methodfurther comprises passing the energy while the energy source is at thefirst subsequent treatment position.

In certain embodiments, a catheter treats a hollow anatomical structure.The catheter further comprises a shaft which extends from a proximal endto a distal end thereof. The catheter further comprises a therapeuticenergy source located at or near a distal end of the shaft. Thetherapeutic energy source forms an energy coupling surface which facesgenerally radially outward from the shaft. At least one fluid deliverychannel extends in a generally radial direction through at least one ofthe energy source and a sidewall of the shaft. The fluid deliverychannel has an outer endpoint positioned in a locally radially outermostregion of the energy source or the shaft.

In certain embodiments, the energy coupling surface of the catheter isfixed relative to the shaft. In one embodiment, the fluid deliverychannel extends through the energy source. In another embodiment, theenergy source of the catheter is an electrode. In certain embodiments,the energy source is a heat emitting element. In one embodiment, theheat emitting element is an electrically resistive heater. In anotherembodiment, the heat emitting element is a heating coil. In certainembodiments, the fluid delivery channel extends through the heatingcoil.

Certain objects and advantages of the disclosed invention(s) aredescribed herein. Of course, it is to be understood that not necessarilyall such objects or advantages may be achieved in accordance with anyparticular embodiment of the invention. Thus, for example, those skilledin the art will recognize that the invention may be embodied or carriedout in a manner that achieves or optimizes one advantage or group ofadvantages as taught herein without necessarily achieving other objectsor advantages as may be taught or suggested herein.

The embodiments summarized above are intended to be within the scope ofthe invention(s) herein disclosed. However, despite the foregoingdiscussion of certain embodiments, only the appended claims (and not thepresent summary) are intended to define the invention(s). The summarizedembodiments, and other embodiments of the present invention, will becomereadily apparent to those skilled in the art from the following detaileddescription of the preferred embodiments having reference to theattached figures, the invention(s) not being limited to any particularembodiment(s) disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view of one embodiment of a device that delivers tumescentfluid with needles.

FIG. 1A is a top view of one embodiment of needles attached to anunrolled expandable stent.

FIG. 1B is a perspective view of the needles and expandable stent ofFIG. 1A when the stent is expanded.

FIG. 1C is a cross-sectional view of the needles and expandable stent ofFIG. 1B.

FIG. 2 is a partial side view of one embodiment of a device thatdelivers pressurized tumescent fluid.

FIG. 3 is a perspective view of another embodiment of a device thatdelivers pressurized tumescent fluid.

FIG. 4 is a side view of the tumescent fluid delivery device of FIG. 3.

FIG. 5 is a perspective view of one embodiment of a device configured todeliver pressurized tumescent fluids.

FIG. 6 is another embodiment of a device configured to deliverpressurized tumescent fluids.

FIG. 7 is a side view of one embodiment of a RF Electrode Therapy devicethat also delivers tumescent fluids with needles.

FIG. 8 is a cross-sectional view of one embodiment of a heating coiltherapy device that also delivers tumescent fluids with needles thatprotrude distal of the coil(s).

FIG. 9 is a cross-sectional view of another embodiment of a heating coiltherapy device that also delivers tumescent fluids with needles thatprotrude at an intermediate distance along the length of the coil(s).

FIG. 10 is a cross-sectional view of another embodiment of a heatingcoil therapy device that also delivers tumescent fluids with needlesthat protrude proximal of the coil(s).

FIG. 11 is a side view of another embodiment of a heating coil therapydevice that also delivers tumescent fluids with needles.

FIG. 12 is a side view of another embodiment of a heating coil therapydevice that also delivers tumescent fluids with needles.

FIG. 13 is a side view of one embodiment of a perforator vein RFElectrode therapy device that also delivers tumescent fluids.

FIG. 14 is a side view of one embodiment of a perforator vein heatingcoil therapy device that also delivers tumescent fluids.

FIG. 15 is a side view showing one embodiment of protruding tumescentinjection holes of the device of FIG. 14.

FIG. 15A is a side view showing another embodiment of protrudingtumescent injection holes of the device of FIG. 14.

FIG. 16 is a partial side view of one embodiment of a perforator vein RFElectrode therapy device that uses needles to introduce tumescentfluids.

FIG. 16A is a perspective view of one embodiment of a perforator vein RFElectrode therapy device that uses needles to introduce tumescentfluids.

FIG. 17 is a partial side view of one embodiment of a perforator veinheating coil therapy device that uses needles to introduce tumescentfluids.

FIG. 17A is the device of FIG. 17 with the needles penetrating the HASwalls.

FIG. 18 is a partial side view of another embodiment of a perforatorvein therapy probe that uses needles to introduce tumescent fluids.

FIG. 19 is a perspective view of one embodiment of a device thatdelivers tumescent fluids from outside the HAS.

FIG. 19A is a front view of the device of FIG. 19 with a fascialenvelope depicted.

FIG. 19B is perspective view of the device of FIG. 19 with a fascialenvelope depicted.

FIG. 20 is a side view of another embodiment of a device that deliverstumescent fluids from outside the HAS.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The features of the system and method will now be described withreference to the drawings summarized above. The drawings, associateddescriptions, and specific implementation are provided to illustrateembodiments of the invention(s) and not to limit the scope of theinvention(s).

In addition, methods and functions described herein are not limited toany particular sequence, and the acts or states relating thereto can beperformed in other sequences that are appropriate. For example,described acts or states may be performed in an order other than thatspecifically disclosed, or multiple acts or states may be combined in asingle act or state.

In some embodiments, a fluid is introduced into body tissue surroundinga vein or other hollow anatomical structure (HAS) to act as a bulkingagent around the HAS, causing a localized diameter reduction. The targetbody tissue may surround a HAS such as a fallopian tube or vas deferens,artery, and vein including but not limited to superficial and perforatorveins, hemorrhoids, esophageal varices, ovarian veins, and varicoceles.Preferably, the fluid is introduced to the fascial envelope, which isthe area surrounding a vessel. Preferably, tumescent anesthesia is thefluid that is introduced. Preferably, over a short period of time,tissue in growth would fill the bulk space, providing a fibrotic“scaffolding” around the vessel. This diameter reduction at or near avalve could promote valve competency restoration.

In some embodiments, the tumescent fluid may be introduced into bodytissue from within the HAS and through the walls of a HAS. In otherembodiments, the tumescent fluid is introduced from outside the HAS.Some embodiments combine the introduction of tumescent fluids withtherapeutic features, such as heating coil therapy or RF Electrodetherapy. Some embodiments relate to a method for compressing ananatomical structure prior to or during the application of energy and anapparatus including an electrode device having multiple leads forapplying energy to the compressed structure to cause it to durablyassume its compressed form.

Some embodiments are directed to a method and apparatus for applyingenergy to a hollow anatomical structure such as a vein, to shrink thestructure. More detailed aspects of these embodiments are directed topre-compressing and exsanguinating a hollow anatomical structure whileproviding anesthetic and insulation benefits during a procedure ofshrinking the hollow anatomical structure.

In another aspect, a method comprises providing fluid to tissuesurrounding a hollow anatomical structure to induce tumescence of thetissue and consequent compression of the hollow anatomical structureduring a procedure of applying energy to the hollow anatomical structurefrom within the structure. In a more detailed aspect, the methodcomprises introducing into the hollow anatomical structure a catheterhaving a working end and at least one electrode at the working end,placing the electrode into contact with the inner wall of thepre-compressed hollow anatomical structure, and applying energy to thehollow anatomical structure at the treatment site via the electrodeuntil the hollow anatomical structure durably assumes dimensions lessthan or equal to the pre-compressed dimensions caused by the injectionof the solution into the tissue.

In another aspect, a method comprises providing fluid to tissuesurrounding a hollow anatomical structure to induce tumescence of thetissue and consequent compression of the hollow anatomical structureduring a procedure of applying energy to the hollow anatomical structurefrom within the structure. In a more detailed aspect, the methodcomprises introducing into the hollow anatomical structure a catheterhaving a working end and at least one electrode at the working end,placing the electrode into contact with the inner wall of thepre-compressed hollow anatomical structure, and applying energy to thehollow anatomical structure at the treatment site via the electrodeuntil the hollow anatomical structure durably assumes dimensions lessthan or equal to the pre-compressed dimensions caused by the injectionof the solution into the tissue.

In a more detailed aspect, tumescent anesthesia fluid is injected orotherwise provided to tissue contiguous with a vein to compress the veinto about a desired final diameter. A catheter having an energyapplication device, such as expandable electrodes, is introducedinternal to the vein at a site within the compressed portion of the veinand energy is applied to the internal vein wall by the applicationdevice. Sufficient energy is applied to cause the vein to durably assumethe compressed diameter such that when the effects of the tumescentanesthesia fluid are dissipated, the vein retains the compresseddiameter.

In some embodiments, the following method is used: (1) Place the devicein the desired location; (2) inject or otherwise introduce tumescentfluid; (3) turn on the therapeutic energy source (RF, Heating Coil, orother). In some embodiments, the tumescent fluid is injected by needlesor by high pressure fluid. In other embodiments, the fluid is releasedand allowed to disperse or mechanically dispersed to the targeted bodytissue.

I. Endovascular/Endoluminal Tumescent Fluid Delivery Systems

Some embodiments comprise a device and method for introducing tumescentfluid into body tissue surrounding a HAS. One possible method forintroducing the tumescent fluid is from within the HAS lumen and throughthe walls of a HAS. Preferably, a catheter is used to insert the deviceinto or through the HAS, and the catheter includes a lumen to positionthe catheter within the HAS. In some embodiments, the shape of thecatheter lumen is triangular, square, oval, semi-circular or amulti-lumen design to facilitate alignment. In some embodiments thedevice includes needles to inject the tumescent fluid through the vesselwalls. In other embodiments, the tumescent fluid penetrates the vesselwalls by way of pressurized fluid flow.

In some embodiments, the endovascular approach includes the followingsteps: (1) Use a compression means and Doppler Ultrasound to identifythe location of the target valve; (2) compress the target region andassess whether the reduced diameter does indeed rectify theincompetence; (3) mark the location on the skin; (4) obtain HAS accessvia a sheath or other suitable means; (5) lay the delivery catheter downonto the skin and mark the distance between the access point and tipusing the target valve position mark on the skin; (6) introduce thecatheter into the vessel and position at the target location; (7) deployextendable needles through the HAS (for embodiments using needles); (8)flush the lumen with the base material until a sufficient volumetumesces the area surrounding the HAS; (9) retract the needles (forappropriate embodiments) and withdraw the catheter; (10) perform apost-op scan to assess valve competence.

A. Needles for Introducing Tumescent Fluid

One embodiment involves a method and device for delivering tumescentfluid to body tissue by using needles to penetrate through a HAS wall.The needles may be flexible and contained within a channel in thecatheter that is separate from a channel containing a lumen. Theflexible needles could be pushed through this channel to penetrate theHAS wall. Alternatively, the needles may be retained in a sliding outersleeve and deployed by retracting the sleeve. It is also contemplatedthat needles are pushed distally to extend beyond the sleeve (opposed toretraction of sleeve). In some embodiments, the needles are extended andretracted by mechanical means. For example, a threaded hub located nearthe proximal end of the device could mate with a threaded luer that isattached to the needles, and rotation of the luer could extend andretract the needles.

There may be any number of needles, and the needles may have anysuitable shape or orientation. For example, the needles could beflexible, and several could be placed around the perimeter of the deviceso as to introduce tumescent fluid to multiple locations around theperimeter of the HAS. Multiple needles may also be oriented radially atthe distal tip of the device. Additionally, it is contemplated that theneedles are in multiple locations along the length of the device tointroduce tumescent fluid along a length of the HAS. In someembodiments, the shape of the needle could be straight when cooled andcurved outward when heated. The temperature of the human body mayprovide the heat to induce the curve in the needle, and cold tumescentfluid could be introduced to return the needle to its cold shape (i.e.Shape-Memory NiTi). In some embodiments, the shape of the needle couldbe predetermined and set so that at body temperature the curve in theneedle is always present when not under load (i.e. Superelastic NiTi).In another embodiment, the needle is configured to telescope, andhydraulic pressure extends the telescoping needle.

Preferably, as shown in FIG. 1 needles 16 are introduced to the interiorof the HAS by way of a catheter 2. Additionally, in some embodiments, alumen is used to introduce and position the needles in the HAS. In someembodiments, impedance is used to sense the location of the needle tip.Preferably, the catheter 2 is configured with an outer shaft 4, tip 8,inner shaft 12, needles 16, needle ramp 20, needle holes 24, and a luer28. In some embodiments, the outer shaft 4 is tubular, and the innershaft 12, needles 16, and needle ramp 20 are located within the outershaft 4. The tip 8 may be located at the distal end of the outer shaft4, and the distal end of the tip 8 may be rounded for HAS trackability.The tip 8 may be sized such that its outer diameter is roughly equal tothe outer diameter of the outer shaft 4. The luer 28 may be connected tothe proximal end of the inner shaft 12, and the luer 28 and inner shaft12 may be moveable with respect to the outer shaft 4. The needles 16 maybe connected at their proximal end to the distal end of the inner shaft12.

In some embodiments, the needles 16, when retracted, extendlongitudinally from the distal end of the inner shaft 12 and are beveledand sharp at their distal end, which is the preferable end to penetratethe body tissue. Preferably, the needles 16 are steel and configured toextend in the radial direction when they contact the needle ramp 20 andspring back to their longitudinal position when retracted. In otherembodiments, the needles 16 may also be preformed to bend radiallyoutward prior to being extended. Additionally, the needles 16 could bemade from nickel titanium and have a preformed shape that bends radiallyoutward when heated. At lower temperatures, the needles 16 may extendlongitudinally, and the heat of the human body may cause them to take ontheir preformed shape (making use of the material's shape-memoryproperties). The needles 16 may also have a preformed shape at alltemperatures above a temperature lower than body temperature so thattheir shape is predetermined and shape change is effected by stressinducing martensite under load from their more stable austenitic form(making use of the material's superelastic properties). Preferably, theneedle ramp 20 is fixed relative to the outer shaft 4 and is locateddistal from the inner shaft 12. The needle ramp 20 may be configuredwith a rounded or sloping surface(s) that angle towards the distal tipfrom the center of the outer shaft 4. The needle holes 24 may be locatedin the outer shaft 4 at a position proximal relative to where the needleramp 20 is fixed to the outer shaft 4. In some embodiments, the needleholes 24 may be covered by a pierceable membrane, and the needles 16 maypenetrate the membrane when extended. In some embodiments, the needlesare configures for simultaneous deployment. Alternatively, the needlesmay be uncoupled and capable of independent deployment.

The catheter 2 may be inserted through the HAS until the needles 16 arepositioned in a desired location. Preferably, the needles 16 arecontained within the outer shaft 4 while the catheter 2 is beingpositioned within the HAS. In some embodiments, after the catheter 2 isin the desired location, the needles 16 extend through the needle holes24 beyond the outside surface of the outer shaft 4 and into the bodytissue surrounding the HAS. The catheter 2 may be configured such that auser can move the luer 28 to move the inner shaft 12 and needles 16relative to the outer shaft 4 and needle ramp 20. In some embodiments,as the needles 16 move distal relative the needle ramp 20, the needles16 contact and slide on the needle ramp 20 such that they bend outwardand extend through the needle holes 24. Preferably, as the needles 16are extended, they penetrate the HAS walls 32 and extend into thesurrounding body tissue. Preferably, there is a pumping mechanism thatsends the tumescent fluid through the inner shaft 12 to the needles 16,such that the fluid is injected into the body tissue after the needles16 have penetrated the HAS walls 32. In some embodiments, the innerdiameter of the needle and/or catheter is increased to accommodatepumped tumescent fluid.

In some embodiments the tumescent fluid is delivered via hooked needles68, as depicted in FIGS. 1A and 1B. The hooked needles 68 may be shapedsuch that their distal ends point at least partially in the proximaldirection. Alternatively, in some embodiments the needles may bestraight and are not hooked. In some embodiments, the hooked needles 68are attached to an expandable stent 74 that is located at or near theproximal end of a catheter or other delivery device. In otherembodiments, the stent 74 may be at other locations relative to thecatheter. In some embodiments, the stent 74 is non-expanded when it isintroduced through the HAS. Preferably, when the hooked needles 68 arein the desired location, the expandable stent 74 is expanded to push thehooked needles 68 out against the HAS wall. The shape of stent-needleconstruct 74 and 68 together may be such that the needles exit thedelivery device at a smaller diameter and the perimeter increases fromits proximal to distal end. In some embodiments, the stent 74 isexpanded and collapsed by mechanical means such as opposing push/pullwires. In other embodiments, the stent 74 may be expanded by use of asilicone balloon. In other embodiments, the stent 74 may expand andcollapse by using the shape-memory or superelastic properties of ShapeMemory Alloys such as nickel titanium. Preferably, after the stent 74 isexpanded and the hook needles 68 are positioned against the HAS wall,they are pulled back and the hooked needles 68 will penetrate the HASwalls. Preferably, tumescent fluid is injected into the surroundingtissue via the hooked needles 68 after the hooked needles 68 penetratethe HAS walls. In some embodiments, there is a common delivery fluidtube that delivers fluid to all of the hooked needles 68, which mayextend through the interior of the catheter. Alternatively, fluid can beindependently delivered to each needle allowing for independent controlof fluid delivery. Preferably, after the tumescent fluid is injected inthe surrounding tissue, the expandable stent 74 is collapsed to retractthe hooked needles 68. In some embodiments, this process is repeatedseveral times to inject tumescent fluid over a desired length of theHAS. Preferably, there are four hooked needles 68 equally spaced alongthe perimeter of the expandable stent 74, but there can be any number ofhooked needles 68. There can also be multiple rows of hooked needles 68attached along the length of the expandable stent 74.

In some embodiments, the device includes a manifold at the proximal hubthat allows one or more of the needles to be turned off or on to fluiddelivery or aspiration. One advantage of this is that tumescent fluidcould be introduced in specific locations relative to the HAS, whichallows for infiltration above a HAS to push it down away from the skin.Additionally, this will allow selective treatment of body tissue andprevent non-targeted body tissue (i.e. other vessels including veins andarteries) from being treated. In a further embodiment, the device maynot include a manifold and each needle or set of needles areindependently injected and aspirated.

Some embodiments include features for determining the directionalorientation of the needle(s) to allow a user to know which needle isdirected anteriorly non-targeted body tissue is not infiltrated. Forexample, there could be a shaft marker located on the shaft to indicatethe orientation of the needle(s) which indicates which way is anterior.Alternatively, there can be a method in which a test infiltration isperformed to observe or visualize where the injection occurred aroundthe vessel. Furthermore, a method may include an aspirating step beforeinjecting tumescent to make sure the needle is outside the vessel (i.e.blood flashback may indicate that the needle is not outside the vessel).

In some embodiments, features are included to ensure that needles arepenetrating the HAS wall and are not in the blood stream, which may beespecially relevant when treating large vessels. In one embodiment, thestroke length of each needle deployment is independently controlled inan uncoupled construct, and in another embodiment the stroke length issimultaneously controlled in a coupled construct. Advantageously, whentreating large vessels this may help to ensure that a single needledoesn't remain in the blood stream. This stroke length could rangeanywhere from about 0.3 cm to 2 cm and is preferably about 0.5 cm to 1cm. In an alternative embodiment, the needles may be aspirated, one at atime, before injecting tumescent to make sure the needles are outsidethe HAS wall (i.e. blood flashback would indicate the needle is notoutside the HAS). In a further embodiment, a balloon is inflated on theshaft near the location where the needle exits to center the shaft inthe center of the vessel so that the needles all equally penetrate theHAS wall when deployed. Another embodiment may apply a vacuum force topull a HAS down to the shaft before deploying the needles.

In some embodiments, the depth of penetration of the needles is limited.For example, stopping features (i.e. raised feature, swaged needle shaftitself, polymer flap, etc.) on the needle shaft proximal to the piercingtip may limit how far the needle can penetrate the vessel wall. It isalso contemplated that the stopping feature could be distal the piercingtip (i.e., for hooked needles). In addition, embodiments that combinethis feature with independent control of deployment or needle strokelength would allow a user to center the catheter in the HAS bymechanically biasing the catheter away from one side of the HAS.Preferably, once the stopping feature engages the vessel wall anyfurther deployment of the needle would push the catheter assembly towardthe center of the lumen (i.e. self centering), which improves thelikelihood that all needles pierce through the vessel wall. Preferably,the stopping features are far enough back from the tip of the needle(s)to allow the sharp tip of the needle to penetrate all the way throughthe vessel wall, but not so far as would damage other structures in thearea or pierce through the skin. For example the distance between thetip of the needle and the stopper is preferably about 0.3 cm to 1 cm,more preferably between about 0.3 cm and 0.6 cm.

In further embodiments, a Piezo electric crystal can be mechanicallycoupled to the needle(s) to vibrate them to allow for ease of HAS wallcutting and penetration.

B. Pressurized Fluid Delivery

In another embodiment as seen in FIG. 2, the tumescent fluid isdelivered through the HAS wall HW by way of pressurized fluid 40. In oneembodiment, a micro-perforating jet 232 is positioned against or nearthe HAS wall HW and pressurized fluid 40 is pumped through themicro-perforating jet 232 such that it contacts and penetrates the HASwall HW and enters the surrounding tissue. FIG. 2 also depicts anelectrode 224, which can be used for therapeutic purposes and isdescribed in more detail below.

In further embodiments, the structure that delivers the pressurizedfluid may be shaped so as to locate and orient the jet 232 andpressurized fluid 40 in a desired position relative to the HAS wall HW.For example, as shown in FIGS. 3 and 4, the pressurized fluid 40 may bedelivered through fluid channel ribs 232 that extend along a catheter200. Preferably, the fluid channel ribs 232 are extendible beyond thedistal end of the catheter outer shaft 210. In the portions that extendbeyond the distal end of the outer shaft 210, the fluid channel ribs 232may be located within an umbrella exsanguinator 230. The shape of theumbrella exsanguinator 230 may be such that the perimeter increases fromits proximal to distal end. Preferably, the umbrella exsanguinator 230is sized to position the distal end of the fluid channel ribs 232against or near the HAS wall. There may be several fluid channel ribs232 located within the umbrella exsanguinator 230, which will allow thepressurized fluid 40 to contact and penetrate the HAS wall in multiplelocations.

In further embodiments as shown in FIG. 5, the high pressure fluid 40may be delivered through a delivery tube 64 that is shaped such that thepressurized tumescent fluid exits the delivery tube 64 in a desireddirection and at a desired location relative to the HAS wall 32. In someconfigurations, this is accomplished with a bowable fluid delivery tube64 that is curved as shown in FIG. 5. In other embodiments, the fluiddelivery tube 64 is corkscrew shaped as shown in FIG. 6. This allowsmultiple exits of the pressurized fluid 40, all of which can bepositioned at or near the HAS wall, which allows pressurized fluid 40 topenetrate the HAS wall in multiple locations.

Preferably, the fluid delivery tubes 64 are made of nickel titanium andare formed such that they are straight at a lower temperature andtransition into a pre-formed shape when heated (making use of thematerial's shape-memory properties. In this manner, the fluid deliverytubes 64 can be inserted within the vein in a roughly straight shape andcan take on the desired shape as the temperature is increased to that ofthe human body. Alternatively, the tubes 64 can exist pre-formed attemperatures of use well below body temperature such that theytransition to a straight shape by stress-inducing a martensitic phasechange in the material while being delivered (making use of thematerial's superelastic properties). However, the fluid delivery tubes64 can be formed according to any known manufacturing methods.

II. Endoluminal Tumescent Fluid Delivery Combined with Vein Therapy

Some embodiments combine delivery of tumescent fluids with HAS therapy.The therapy may consist of coagulating and/or constricting a HAS inorder to inhibit or stop fluid flow therethrough. By “constricting,” itis meant that a portion of the lumen of the treated HAS is reduced insize so that fluid flow therethrough is either reduced or stoppedentirely. Usually, constriction will result from endothelial denudation,a combination of edema and swelling associated with cellular thermalinjury, and denaturation and contraction of the collagenous tissuesleading to a fibrotic occlusion of the HAS so that fluid flow is reducedor stopped entirely. In other cases, constriction could result fromdirect fusion or welding of the walls together, typically when pressureand/or energy are applied externally to the HAS. Such heating may occuras a result of the application of energy directly to the walls of theHAS and/or to the tissue surrounding the HAS. Preferably, this energy isprovided consistent with known therapies, such as RF electrode therapy,heating coil therapy, or perforator vein therapy. In some embodiments,the therapy includes the following steps: (1) Place the device in thedesired location; (2) extend the needle(s) through the HAS wall (forneedle embodiments); (3) inject tumescent fluid; (4) turn on thetherapeutic energy source (RF, Coil, or other); (5) move the deviceaxially/longitudinally within the HAS to a new, adjacent treatmentlocation and repeat steps 2 through 4. In some embodiments, tumescentfluid is introduced into a section surrounding the HAS while therapy isbeing provided to another section. This allows two actions to beconducted simultaneously, which may increase the efficiency of thetreatment. It is contemplated that all embodiments of introducingtumescent fluid to body tissue can be combined with HAS therapytechniques. However, in some embodiments, the two actions may not beconducted simultaneously because the time necessary for the tumescentfluid to be injected and to take effect can require a longer durationthan the time necessary for the therapeutic energy source to takeeffect. For a more efficient and effective result, tumescent fluid canbe administered with more than one needle.

A. RF Electrode Therapy Combined with Tumescent Fluid Delivery

In some embodiments, an HAS treatment device includes a catheter withelectrodes, which can be used to provide RF therapy to a HAS. In someembodiments, the catheter may include an expandable electrode devicethat moves in and out of the distal end of the catheter's outer shaft210. Preferably, the electrode device includes a plurality of electrodes224 which can be expanded by moving the electrodes 224 within the shaft210, or by moving the outer shaft 210 relative to the electrodes 224. RFElectrode Therapy devices and methods are described in more detail inU.S. Pat. No. 6,769,433, issued on Aug. 3, 2004 to Zikorus et. al.,titled EXPANDABLE VEIN LIGATOR CATHETER HAVING MULTIPLE ELECTRODE LEADS,AND METHOD, which is hereby incorporated by reference herein and made apart of this specification.

1) Pressurized Tumescent Fluid Combined with RF Electrode Therapy

In some embodiments, RF electrode therapy is provided in combinationwith a tumescent fluid delivery system that delivers pressurized fluidthrough the HAS wall with a micro-perforating jet, as depicted in FIGS.2-6. Preferably, one or more electrodes 224 are located on a treatmentcatheter distal of one or more micro-perforating jets 232, as depictedin FIG. 2, but it is contemplated that they could be positionedotherwise. The electrodes 224 may be positioned for delivery into theHAS within a surrounding or overlying structure that delivers thepressurized fluid 40. For example, as shown in FIGS. 3 and 4, theelectrodes 224 may be folded within an umbrella exsanguinator 230 andouter shaft 210 during insertion into the HAS and then, after insertion,be moved distally relative to the umbrella 230 and outer shaft 210 todeploy the electrodes 224. Alternatively, the umbrella 230 and outershaft 210 may be moved proximally relative to the electrodes 224.

FIGS. 2-4 show an HAS treatment catheter 200 which includes an electrodedevice having multiple electrodes for applying energy to shrink a hollowanatomical structure. This catheter can be used to treat varicose veinsby way of ligation. Alternatively, this catheter can be used to treatvaricose veins by collagen contraction and cellular necrosis of thevessel wall leading to ultimate fibrotic occlusion of the vessel lumen.This occlusion, cauterization, and/or coagulation of the vascular luminacan be accomplished using electrical energy applied through an electrodedevice. A treatment device such as the catheter 200 is introduced intothe vein lumen and positioned so that it contacts the vein wall. Oncethe catheter is properly positioned, RF energy is applied to the veinwall through the electrode device thereby causing the vein wall toshrink in cross-sectional diameter. A reduction in cross-sectionaldiameter, for example from 5 mm (0.2 in) to 1 mm (0.04 in) or more oftenfrom larger diameters of 8-16 mm (0.35 in-0.63 in) in 1 mm (0.04 in),significantly reduces the flow of blood through the vein and results inan effective occlusion and/or ligation.

In some embodiments, the treatment catheter 200 is comprised of an outercatheter shaft 210, and an inner shaft 220 and surrounding umbrellaexsanguinator 230 which are slidingly received within a lumen 212 of theouter shaft 210. The inner shaft 220 and umbrella 230 may be slidabletogether as a unit within the outer shaft lumen 212, or they may beseparately and independently slidable. An HAS constriction energy sourcein the form of an electrode array 222 is mounted on the inner shaft 220,and includes one or more radially expandable electrodes 224. The innershaft 220 preferably includes an atraumatic tip 226 at the distal endthereof, to minimize tissue injury as the catheter 200 is passed througha narrow HAS.

In additional embodiments, an HAS constriction energy source in the formof one or more heating elements is disposed on the inner shaft 220 orouter shaft 210, and preferably at or near a working end or distal endof the shaft 220/210. In one embodiment, the heating element comprisesan electrically resistive coil, but in alternative embodiments any othersuitable heat-emitting device may be employed, such as otherelectrically resistive heaters, a fluid-conducting heat exchanger, achemical reaction chamber, etc. The heating element employed on theshaft 220/210 can be generally similar to the various embodiments ofheating elements discussed elsewhere herein. Additionally, where aheating element is employed the proximal portion of the shaft 220/210may include indexing marks as discussed elsewhere herein to facilitate“indexed” operation of the heating element to treat an HAS.

The umbrella 230 preferably includes one or more radially expandabletransmural fluid delivery channels in the form of fluid channel ribs232, and a membrane 234 which is supported by the fluid channel ribs232. (The functions of the fluid channel ribs 232 and membrane 234 willbe discussed in greater detail below.) In alternative embodiments of thecatheter 200, the membrane 234 can be omitted such that the umbrella 230includes only the fluid channel rib(s) 232. In still furtherembodiments, fewer than all of the ribs 232 include fluid channelstherein; in other words, one or more of the ribs can be simplestructural members without fluid conducting capabilities.

The catheter 200 can be manipulated into a low-profile configuration(not shown) which is suitable for inserting the catheter into a patientpercutaneously and passing the working end or distal end 202 of thecatheter into a narrow HAS such as a varicose vein. In the low-profileconfiguration the inner shaft 220, with its electrodes 224, and theumbrella 230, with its ribs 232, are withdrawn proximally into the lumen212 of the outer shaft 210 such that the electrodes 224 and ribs 232 arecontracted radially towards or against the inner shaft 220, and arecovered by the outer shaft 210. Where the inner shaft 220 is slidablerelative to the umbrella 230, the inner shaft 220 may be withdrawn intothe umbrella 230 when the catheter 200 is in the low-profileconfiguration, such that some portion or all of the electrodes 224 maybe received within and covered by both the umbrella 230/membrane 234,and the outer shaft 210. When the catheter 200 is in the low-profileconfiguration, the atraumatic tip 226 is preferably partially receivedin and fills the distal opening of the outer shaft, to create an overallsmooth atraumatic distal end of the catheter 200.

After insertion of the distal end 212 of the catheter 200 to thetreatment site within the HAS, the catheter 200 is manipulated into thedeployed, high-profile configuration shown in FIGS. 2-4. To change thecatheter 200 to the deployed configuration the outer shaft 210 iswithdrawn proximally, and/or the inner shaft 220 and umbrella 230 areadvanced distally, to expose the electrodes 224 and ribs 230. (Where theinner shaft 220 is moveable relative to the umbrella 230, the innershaft may be advanced further distally, to expose the electrodes 224fully.) Due to their self-expanding properties, the electrodes 224 andribs 230 attain the expanded configuration on their own after removal ofthe outer shaft 210. Preferably, the electrodes 224 and ribs 230 areformed from a material such as spring steel or nitinol to ensuresufficient expandability.

As shown in FIG. 2, some or all of the radially outermost portions ofthe electrodes 224 and ribs 232 are preferably in firm contact with theHAS wall HW when the catheter 200 is in the deployed configurationwithin the treatment area of the HAS. At this point a micro-perforatingjet of high-pressure fluid 40, preferably a tumescent fluid, isconducted through the fluid channels 236 of one or more of the ribs 232,out the rib tip(s) 238, through the HAS wall HW and into the tissuesurrounding the HAS. Where the fluid 40 comprises a tumescent agentand/or a bulking agent, the fluid causes swelling and/or bulking of thesurrounding tissues such that the HAS walls are constricted, which inturn improves (or causes) apposition of the electrodes 224 with the HASwall HW.

After any such swelling/bulking takes effect, the HAS (e.g. a varicosevein) is treated with HAS constriction energy delivered by theelectrodes 224, to permanently constrict/occlude the HAS. Preferably theHAS constriction energy comprises RF energy. The RF energy is convertedwithin the adjacent venous tissue into heat, and this thermal effectcauses the venous tissue to shrink, reducing the diameter of the vein.The thermal effect produces structural transfiguration of the collagenfibrils in the vein. The collagen fibrils shorten and thicken incross-section in response to the heat from the thermal effect.

The energy causes the vein wall HW to collapse around the electrodes224. The wall continues to collapse until impeded by the electrodes 224.The electrodes are pressed together by the shrinking vein wall untilthey touch; and at that point, further collapse or ligation of the wallis impeded. In some embodiments, the catheter 200 is pulled back whileenergy is applied to the electrode device.

In either bipolar or monopolar operation of the electrode array 222, theapplication of RF energy is preferably substantially symmetricallydistributed through the vein wall, regardless of the diameter of thevein. This symmetrical distribution of RF energy increases thepredictability and uniformity of the shrinkage and the strength of theresulting occlusion. The RF energy may be within a frequency range of250 kHz to 350 MHz; one suitable frequency is 510 kHz. The preferablefrequency is 460 kHz.

Optionally, an exsanguinating fluid and/or dielectric fluid can bedelivered into the HAS lumen before and during RF heating of the vein.The treatment area of the HAS/vein can be flushed with a fluid such assaline, or a dielectric fluid, in order to evacuate blood from thetreatment area of the vein so as to prevent the formation of coagulum orthrombosis. To facilitate delivery of such fluid(s), an additional lumencan be provided in the outer shaft 210 of the catheter 200, or the tip238 of one or more of the fluid channel ribs 232 can be configured topoint distally when deployed, to permit delivery of an exsanguinatingfluid and/or dielectric fluid into the HAS lumen and not through the HASwall HW. However delivered, the exsanguinating/dielectric fluiddisplaces or exsanguinates blood from the vein so as to avoid heatingand coagulation of blood. Fluid can continue to be delivered during RFtreatment to prevent blood from circulating back to the treatment site.The delivery of a dielectric fluid increases the surrounding impedanceso that RF energy is directed into the tissue of the vein wall. Wherepresent, the membrane 234 of the umbrella 230 facilitates theexsanguination of the treatment area by forming a wall which impedes themigration of blood into the treatment area after the exsanguinatingfluid is delivered.

The catheter 200 has a connector (not shown) near its proximal end thathas the capability of interfacing with a power source 240. The powersource 240 is typically an RF generator, but any other suitable powersource may be employed. The proximal end of the catheter 200 may alsoinclude appropriate hubs, valves and/or fittings to facilitate fluidcommunication between the fluid channel ribs 232 and a tumescent fluidsource 250.

The electrode array 222 depicted in FIGS. 3-4 comprises a plurality ofelectrodes 224; if desired, the atraumatic tip 226 can, serve as acentral electrode. In the depicted embodiment, the electrode array 222has a diameter of approximately 12 mm when expanded and unconfined, andthe distal end of the umbrella 230 has a diameter of approximately 20 mmwhen expanded and unconfined.

The structure and operation of RF electrode array 222 can, in certainembodiments, be generally similar to the RF therapy apparatus andmethods disclosed in U.S. Pat. No. 6,769,433, mentioned and incorporatedabove.

2) Tumescent Fluid Injected by Needles Combined with RF ElectrodeTherapy

In some embodiments, the introduction of tumescent fluids, via one ormore needles, from within an HAS to body tissue surrounding an HAS maybe combined with a RF Electrode therapeutic device and method. As shownin FIG. 7, the tumescent fluid can be delivered in conjunction with theRF Electrode therapy device such that one delivery device, e.g. thecatheter 200 of FIGS. 2-4, modified to incorporate needles 330 as shownin FIG. 7, provides the RF therapy, as well as the tumescent fluid. Inthis embodiment needles 330, as depicted in FIG. 1 or FIGS. 8-10 anddescribed elsewhere herein, are used to deliver the tumescent fluid intothe tissue surrounding the HAS. Preferably, the needles 330 are locatedwithin the outer shaft 210 and employ an extension/retraction mechanismsimilar to that shown in FIGS. 1 and 8-10. In some embodiments, theneedles 330 function as electrodes. Preferably, the RF electrodes 224and the needles 330 are moveable with respect to the outer shaft 210.The needles 330 may be in any location relative to the RF electrodes224, but it is preferable that they are proximal relative to the RFelectrodes 224. The configuration, mechanics and function of the needles330 can otherwise be generally similar to the device of FIG. 1 or theneedles 330 of FIGS. 8-10. Generally, the catheter 200 of FIG. 7 issimilar in structure, function and use to the catheter 200 of FIGS. 2-4,except as further described herein with regard to FIG. 7.

The embodiment of the catheter 200 shown in FIG. 7 can be operated totreat an HAS in a manner similar to that described for the catheter 200of FIGS. 2-4, except that the needles 330 are employed to delivertumescent fluid (and/or a bulking agent or drug) as described withregard to the embodiment of FIGS. 8-10. The catheter 200 is insertedinto a hollow anatomical structure HAS such as the depicted vein. Thecatheter 200 can further include an external sheath 290 through whichthe catheter and, if desired, an exsanguinating or dielectric fluid canbe delivered to the treatment site in the HAS. In some embodiments, thetumescent fluid or other fluids are delivered through at least oneneedle 330. In some embodiments, fluid is delivered through a pair ofneedles 330 positioned on the top end and the bottom end of the catheter200, as shown in FIG. 7.

B. Heating Coil Therapy Combined with Tumescent Fluid Delivery

In some embodiments, endoluminal tumescent fluid delivery as disclosedherein is used in conjunction with a heating coil therapy systemcomprising a catheter with a heating coil or other heating element nearthe distal end thereof, and one or more radially deployable needles fordelivering tumescent fluid. In some embodiments, catheter is employed totreat a HAS having an inner wall. Preferably, the heating element has alength and a width measured orthogonal to its length; its length ispreferably greater than its width. The catheter may be placed in a firstposition within the HAS and the needle(s) deployed to deliver tumescentfluid endoluminally through the HAS wall near the first position. Afterthe tumescent fluid takes effect, the heating element may be operated toemit heat from substantially all of its length into the inner wall ofthe HAS at the first position. In some embodiments, the element issubsequently moved, after emitting heat in the first position, to asecond position within the HAS by a longitudinal or axial distancecorresponding to approximately the heating coil's length. In someembodiments, the distance is approximately equal to the length of theheating coil minus a desired overlap distance. While the catheter isstationary in this second position, the needles are deployed and used todeliver tumescent fluid near the second position. After the tumescentfluid takes effect in the second position, the heating element is againoperated and again emits heat into the inner wall along substantiallythe length of the element. Therapy performed with a heating element forHAS treatment is described in more detail in U.S. ProvisionalApplication No. 60/780,948, filed Mar. 9, 2006, entitled SYSTEMS ANDMETHODS FOR TREATING A HOLLOW ANATOMICAL STRUCTURE, which is herebyincorporated by reference herein and made a part of this specification.

1) Tumescent Fluid Injected by Needles Combined with Heating CoilTherapy

FIGS. 8-10 depict several embodiments of an HAS treatment catheter 300which generally comprises a catheter shaft 310, one or more heatingelements 320 disposed on the shaft 310, and one or more radiallyexpandable or deployable needles 330 which can be employed to delivertumescent fluid through an HAS wall HW. The heating element 320 ispreferably disposed on an outer surface of the shaft 310, and preferablyat or near a working end or distal end 312 of the shaft. In the depictedembodiment, the heating element 320 comprises an electrically resistivecoil, but in alternative embodiments any other suitable heat-emittingdevice may be employed, such as other electrically resistive heaters, afluid-conducting heat exchanger, a chemical reaction chamber, etc. Inother embodiments, one or more electrodes or RF electrodes (includingbut not limited to the electrode array 222 disclosed herein) can bedisposed on the shaft 310 at or near the distal end thereof, andemployed to treat an HAS with RF energy as described herein.

The needle(s) 330 are moveable from a retracted position (not shown) inwhich each needle 330, including each needle tip 332 thereof, iswithdrawn into a needle lumen 314 of the shaft 310, to a deployed orradially expanded position as shown in FIGS. 8-10 wherein the tip 332 ofeach needle is displaced radially outward from the longitudinal axis ofthe catheter shaft 310, and radially outward from the sidewall 316 ofthe shaft 310. When the distal end 312 of the catheter 300 is positionedwithin a lumen of an HAS as depicted, movement of the needle(s) 330 tothe deployed position can cause the needle(s) to penetrate the HAS wallHW such that the needle tip(s) 332 are disposed in the tissuesurrounding the HAS.

The deployment and retraction of the needle(s) 330 is preferablyaccomplished by distal and proximal movement, respectively, of eachneedle 330 along the corresponding needle lumen 314. As each needle 330is moved distally, the needle tip 332 thereof emerges from thecorresponding lumen 314 and moves radially away from the longitudinalaxis of the shaft 310. In one embodiment, each needle 330 has a heat-setdistal curve 334 which prevails when the needle end is unconstrained,such as when the needle end is urged near the end of the needle lumen314. Such a heat-set curve is straightened when the needle is withdrawninto the lumen.

In the embodiment of FIG. 8, the needle lumen 314 terminates in anaxially-facing lumen opening 318 distal of the heating element 320,which permits the needle end to curve and extend radially, distal of theheating element 320, as the needle end emerges from the lumen opening318. Thus the needle tip 332 can be directed toward and penetrate theHAS wall HW at a penetration location distal of the heating element'sposition within the HAS.

In the embodiment of FIG. 9, the needle lumen 314 terminates in aradially-facing sidewall port 352, and an optional ramp 354 can beprovided to urge the needle tip 332 in the radial direction as theneedle 330 is urged distally. Thus the needle tip 332 emerges radiallyfrom the port 352 and moves toward and penetrates the HAS wall HW. Inthis embodiment, and in the embodiment of FIG. 10, no heat-set curve 334is believed necessary to facilitate radial movement of the needle tip332, although such a curve may be employed in any event. The port 352and ramp 354 are positioned midway along the length of the heatingelement 330 so that the needle tip 332 can be directed toward andpenetrate the HAS wall HW at a penetration location coincident with theheating element's position within the HAS, facilitating accurateinjection of tumescent fluid.

The embodiment of FIG. 10 is generally similar to that shown in FIG. 9,with the exception that the port 352 and ramp 354 are positionedproximal of the heating element 330 so that the needle tip 332 can bedirected toward and penetrate the HAS wall HW at a penetration locationproximal of the heating element's position within the HAS. In theembodiments of FIGS. 9 and 10, the ramp 354 can be formed by theproximal end of a filler plug that occupies the distal extremity of theneedle lumen 314.

In one embodiment, injection tubing 360 extends proximally from each theneedle 330, towards the proximal end of the catheter 300 to providefluid communication between the needle 330 and a source of tumescentfluid (not shown).

Preferably, each needle 330 has a beveled and sharp tip 332 at thedistal end thereof. The needle tip(s) 332 may be beveled in anydirection so as to introduce fluid in a desired direction. In someembodiments, the needle has a sharp tip with a fluid delivery port onthe tip, facing axially relative to the longitudinal axis of the needle,or alongside the tip, facing radially relative to the longitudinal axisof the needle. The preferred direction of the bevel can vary dependingon the location of the coil(s) 320 with respect to the location of theneedle(s) 330, so as to direct the tumescent fluid toward the area to betreated with the coil.

As seen in FIGS. 8-10, the shaft 310 preferably includes a guidewirelumen 370 to facilitate insertion of the catheter 300 into an HAS over apreviously-inserted guidewire (not shown).

In some embodiments of the catheter 300, multiple needle(s) 330 areemployed which extend from positions spaced at radially-separatedintervals (e.g., at the 12 o'clock, 4 o'clock and 8 o'clock positions asthe shaft 310 is viewed axially). In embodiments where multiple needlesare employed, the needles can extend from positions that arelongitudinally spaced along the shaft 310, including any one orcombination of the various positions identified relative to the heatingcoil 320 and depicted in FIGS. 8-10. Furthermore, the catheter 300 couldinclude multiple sets of expanding needles which are radially spacedabout the shaft 310 as detailed above, with the needle sets spaced apartalong the length of the shaft 310.

In certain embodiments, the heating element 320 is an electricallyresistive heating element, including but not limited to any of thosedescribed elsewhere herein. For example, the heating element maycomprise a single, bifilar or other electrically resistive wire. Certainembodiments of the heating element 320 comprise a wire havingtightly-wrapped coils around a hollow, elongate structure. The heatingelement may comprise a loose, tight, or variable-pitch coil wound arounda solid or hollow elongate structure.

In certain embodiments, the heating element 320 has a substantiallyshort axial length. For example, in certain embodiments, the heatingelement has a length of between approximately one centimeter andapproximately ten centimeters. Such a length is believed to beparticularly advantageous for embodiments utilizing manual, externalcompression to treat a HAS. In certain preferred embodiments, the lengthof the heating element 320 is approximately seven centimeters.

In certain embodiments, the heating energy delivered by the heatingelement 320 is less than 100 watts. In a more preferred embodimentusable in an indexing process, the heating energy delivered by theheating element 320 is between approximately five watts and twentywatts.

Thus, in some embodiments an HAS treatment catheter has a catheter shaftwhich extends from a proximal end to a distal end thereof; a therapeuticenergy source located at or near a distal end of the shaft; and at leastone fluid delivery channel located in the shaft. The therapeutic energysource can comprise an electrode or a resistive heating element, or anyother suitable energy source. In some embodiments, as illustrated inFIG. 8, the therapeutic energy source is a heating coil element. Thefluid delivery channel located in the shaft has a channel having adelivery tip which is movable from a retracted position near alongitudinal axis of the shaft, to a deployed position farther from thelongitudinal axis. In some embodiments, such as the embodimentsillustrated in FIGS. 8-10, the fluid delivery channel comprises at leastone needle.

In use, the catheter 300 is inserted into an HAS such that the distalportion of the catheter, including the heating element 320 orelectrode(s), are in the intended treatment area of the HAS. Once thecatheter is properly positioned, the needle(s) 330 are extended as shownin FIGS. 8-10, so that the needles penetrate the HAS wall HW and theneedle tips 332 are disposed within the tissue surrounding the HAS.Tumescent fluid and/or a bulking agent is then conducted from anexternal tumescent fluid source or bulking agent source to the needles,and then injected out the tips of the needles into the target tissue,which swells and/or bulks in reaction to the fluid/agent which isinjected. (In some instances, sufficient time should be allotted fortumescent fluid to take effect. In some embodiments, the HAS therapytechnique will last for a short duration in comparison to the timenecessary for the tumescent fluid to be injected and to take effect.Additionally, the tumescent fluid is preferably distributed evenly alongthe fascial envelope around the HAS/vein in order to affect the targetportion of the vein.)

Contemporaneously with injection of the tumescent fluid or bulkingagent, or after some time interval has passed after injection andretraction of the needle(s) (e.g. to permit the fluid/agent to takeeffect and cause constriction of the HAS near the heating element 320),power is applied to the heating element 320 (or electrodes). The heatingelement 320 emits heat into the adjacent portions of the HAS wall HW,which preferably has reduced in diameter by virtue of the injection andis in good thermal contact with the heating element. The heat emittedinto the HAS wall in turn causes the wall to shrink, reducing thediameter of the HAS. The thermal effect produces structuraltransfiguration of the collagen fibrils in the wall. The collagenfibrils shorten and thicken in cross-section in response to the heatfrom the thermal effect, causing the HAS wall HW to collapse around theheating element 320. Thus is formed a durable occlusion in the HAS.After heat has been emitted for a sufficient time, the heating element320 is turned off (and the needles retracted if still in the expandedposition) and withdrawn or moved to a second treatment position withinthe HAS.

In some embodiments, the heating element 320 is progressively movedthrough the HAS in a series of discrete steps from a first position to afinal position in order to treat a desired contiguous length of the HAS.The process of moving a heating element through an HAS in a series ofdiscrete steps during treatment is referred to herein as “indexing.”

A general indexing process may proceed by advancing the heating element320 to a distal-most position, injecting tumescent fluid and/or abulking agent with the needle(s) 330, and applying power to the heatingelement while the heating element remains stationary at the distal-mostposition. The temperature of the subject heating element is allowed toramp up or increase to a desired temperature and remains in place for adesired dwell time, e.g. 25 seconds. Once the desired dwell time isreached (e.g., the treatment for the section is completed), the heatingelement can be powered down, and the element can be indexed proximallyto a second position, at which point at least one of the injection, rampup, dwell, power down, and indexing procedures may be repeated.

In certain embodiments, in order to accurately index the heating element320, it is desirable to provide a means for repeatedly moving (orfacilitating accurate, repeated movement of) the heating elementproximally within an HAS undergoing treatment by a desired distance. Incertain embodiments, this desired distance is less than the overalllength of the heating element so as to effectively re-treat regions thatmay receive less heat energy as a result of an uneven heating profilealong the axial length of the heating element. It may also be desirableto treat more than once an initial and/or final treatment region of theHAS in order to arrange for start- and endpoints of the indexingdistances to correspond with catheter shaft markings or to arrange that,after the full series of indexed treatments, the final HAS treatmentregion is in substantial alignment with the end of the introducersheath. In addition, in certain embodiments, the system includes meansfor preventing the heating element from being powered up while it iswithin the introducer sheath.

In certain embodiments, the catheter shaft 310 may comprise a pluralityof markings not shown along the axial length thereof, proximal of theheating element 320, in order to facilitate visual verification ofindexing positions. Such markings advantageously assist a user inpositioning and indexing the heating element 320 of the catheter 300during treatment. For example, the user may determine from the markingshow far the heating element 320 should be retracted during a treatmentinterval.

In certain embodiments, the physician uses the markings to manually andselectively move the catheter 300 within a HAS of a patient. Forexample, the heating element 320 of may extend approximately sevencentimeters in length. In such an embodiment, the markings may be spacedapart at approximately 6.5 centimeter intervals along the shaft 310.When treating the patient, the physician may use the markings tomanually withdraw from the HAS the catheter 300 at 6.5 centimeterintervals between successive inject-and-heat treatments of the HAS. Sucha 6.5 cm movement can be performed by proceeding from a first state inwhich a first shaft marking is aligned with a fixed reference point(e.g., the proximal edge of the introducer sheath hub or other datumdevice), then moving the catheter shaft 310 proximally (or distally) toreach a second state in which a proximally (or distally) adjacent secondshaft marking is aligned with the fixed reference point. In otherembodiments, a device may be used to automatically withdraw the catheterat the predetermined intervals indicated by the markings.

In further embodiments as shown in FIG. 11, the heating coil 320 maycomprise a flexible and “free” spring coil 320 which is deployed in theHAS lumen and permitted to form a helix which conforms to the HAS insidediameter. An array of needles in the form of spikes 380 can be locatedradially within the spring coil 320. The spikes 380 are configured topenetrate the HAS wall HW and introduce tumescent fluid into thesurrounding tissue. The spikes 380 may penetrate the HAS wall HW whenthe HAS wall HW and spring coil 320 are compressed down to a diameterthat is less than the diameter or width of the spikes (which compressionchanges the coil 320 from the relaxed configuration shown in FIG. 11 tothe collapsed configuration shown in FIG. 12). In some embodiments, theHAS walls may be compressed by applying a vacuum to the interior of theHAS such that the force of the vacuum collapses the HAS walls HW andspring coils 320 to a smaller diameter, thereby impaling the spikes 380through the HAS walls HW to introduce the tumescent fluids into thesurrounding tissue. Instead of or in addition to application of avacuum, the tissues surrounding the HAS may be manually compressed ontothe spikes 380 by applying extracorporeal, manual pressure or applying atight bandage above or around the location of the coil 320 and spikes380. (In general, compression of the HAS diameter down to a diameterless than the outside diameter of the tumescent fluid delivery needlesor spikes is also assisted by delivery of the tumescent fluid itselfwhich acts to compress and exsanguinate the HAS as it fills the fascialenvelope.) Heat is then generated with the coil 320 in the usual mannerto cause a durable occlusion of the HAS.

2) Pressurized Tumescent Fluid Combined with Heating Coil Therapy

In some embodiments, the delivery of tumescent fluid to body tissue byhigh-pressure is combined with the heating coil or heating elementtherapy. These pressure jets can be in any location relative to thecoil(s). In some embodiments, the action of the pressure jetspenetrating the vein wall is improved by compressing the vein againstthe catheter during fluid jetting.

With regard to the embodiment of FIGS. 2-4, an HAS constriction energysource in the form of one or more heating elements can be disposed onthe inner shaft 220 or outer shaft 210, and preferably at or near aworking end or distal end of the shaft 220/210. In one embodiment, theheating element comprises an electrically resistive coil, but inalternative embodiments any other suitable heat-emitting device may beemployed, such as other electrically resistive heaters, afluid-conducting heat exchanger, a chemical reaction chamber, etc. Theheating element employed on the shaft 220/210 can be generally similarto the various embodiments of heating elements discussed elsewhereherein. Additionally, where a heating element is employed the proximalportion of the shaft 220/210 may include indexing marks as discussedelsewhere herein to facilitate “indexed” operation of the heatingelement to treat an HAS.

C. Perforator Vein Therapy Combined with Tumescent Delivery

In some embodiments the delivery of tumescent fluid may be accomplishedin combination with perforator vein therapy. In some embodiments ofperforator vein therapy, constricting a target HAS comprisespercutaneously introducing a distal end of a probe 400, such as thosedepicted in FIGS. 13 and 14, to a location in the HAS and deliveringenergy into the target HAS to constrict the target region of the HAS. Insome embodiments the probe 400 is stiff and in other embodiments theprobe 400 is flexible. The probe 400 may be introduced by advancing asharpened distal end thereof through tissue directly to the targetregion, by positioning a sheath through tissue to the target region andadvancing the probe through the sheath, or by positioning a guidewirethrough a needle, removing the needle, and advancing the probe over theguidewire to the location near the target HAS. In some embodiments, theprobe is inserted within the target HAS and therapy is applied to theinner wall. Perforator vein therapy may utilize RF electrodes, heatingcoils, as well as other sources of therapeutic energy.

1) Pressurized Tumescent Fluid Combined with Perforator Vein Therapy

Perforator veins connect the deep venous system of a leg to thesuperficial venous system or surface veins which lie closer to the skin.Normal or healthy perforator veins pass blood from the surface veins tothe deep veins as part of the normal blood circulation. Incompetentperforator veins allow blood flow from the deep venous system to thesurface veins, causing or contributing to problems, such as varicoseveins, edema, skin and soft tissue changes, lipodermatosclerosis,chronic cellulites, venous ulcers, and the like.

FIG. 13 depicts one embodiment of a probe 400 which can be used toperform perforator vein therapy and which includes features to introducehigh pressure tumescent fluid such that it penetrates the walls of a HASin which the probe is inserted and reaches the surrounding body tissue.The probe 400 generally comprises an outer shaft 410, an inner shaft 420which is received within and generally coaxial with the outer shaft 410,and a pair of proximal and distal electrodes 430, 432 positioned at thedistal end of the shafts. Preferably the distal tip 434 of the distalelectrode 432 forms an opening to a lumen 422 of the inner shaft 420.

An annular space 424 is formed between the outer and inner shafts 410,420 and provides a fluid flow path from a proximal end (not shown) ofthe probe 400 to one or more fluid injection channels 450 formed in theproximal electrode 430. Alternatively, the inner shaft 420 may beshorter than and bonded to the outer shaft 410 near the distal end withthe fluid injection channels 450 traversing through both shafts to theinner lumen of the inner shaft 420 (in this case the distal tip 434would be permanently closed or plugged with a removable feature). Thus ahigh-pressure fluid 40, such as a tumescent fluid, bulking agent, drug,etc. can be delivered from a source of the fluid/agent/drug (not shown)in fluid communication with the annular space 424 and injection channels450, distally down the annular space 424, through and out the injectionchannels 450 and into an adjacent HAS wall HW. To facilitate goodapposition of the outermost ends or ports 452 of the injection channels450 against the HAS wall HW, the channels 450 and outermost ends 452 arepreferably positioned in a locally radially outermost region of theelectrode 430. (Alternatively, the channels 450 can extend through theouter shaft 410 proximal of the electrodes 430, 432; if so, the channels450 and outermost ends or ports 452 are preferably positioned in alocally radially outermost region of the shaft 410.)

In use, the probe 400 is inserted into an HAS or perforator veinpercutaneously and the distal portion thereof is maneuvered into thedesired treatment location within the HAS. Once the probe is properlypositioned, pressurized fluid (e.g. tumescent fluid) is conducted from afluid source, distally down the annular space 424 (in this embodiment),through the channels 450 and out the ports 452. The pressurized fluidpenetrates through the adjacent HAS wall HW, and spreads into the tissuesurrounding the HAS. This causes the tissue to swell and constrict theHAS wall HW such that the electrodes 430, 432 are in close apposition tothe HAS wall. An electrical current, such as an RF electrical current,is then applied to the electrodes 430, 432 so that RF energy is passedthrough the HAS wall near the electrodes. As discussed elsewhere herein,the RF energy heats the HAS wall, causing a durable shrinkage andligation or occlusion of the HAS. The probe can be drawn proximally asthe energy is applied to the tissue, treating an extended length of thevein to form a long ligation or occlusion.

Additionally, the probe 400 can be employed to treat quadrants of theHAS or vessel sequentially. The probe 400 is tilted toward one quadrantof the vessel and used to treat the selected quadrant and then tiltedtoward the next quadrant of the vessel and used to treat that quadrant,which cycle is then repeated to affect 360 degrees of the vesseldiameter at the treatment location. For example a first quadrant at a 0degrees position for 1 minute of RF energy application, a secondquadrant at a 90 degrees position for 1 minute of RF energy application,a third quadrant at a 180 degrees position for 1 minute of RF energyapplication, and a fourth quadrant at a 270 degrees position for 1minute of RF energy application. After treating around the vessel wallcircumference at one location in this manner, the probe is advancedlongitudinally to another location where the circumference is againtreated in this sequential-quadrant manner. An injection of tumescentfluid is preferably made with the probe 400 before some or all of thesequential-quadrant treatment cycles.

In some embodiments, the probe 400 is operated in a bipolar mode toconstrict a target perforator vein. As illustrated in FIG. 13, the probe400 is rigid but it could also have flexible shafts 410, 420. The probe400 can be inserted into the HAS/vein through an introducer sheath orcannula, but alternatively the insertion can be performed by “directly”penetrating the vein with a probe 400 having a needle or trocar in thecentral lumen 422 or having a sharpened distal electrode 432. Afterinsertion of the probe, the electrodes are energized as the probe isdrawn back to contact the opposite side of the vein or other HAS. Thevein or other HAS is heated and collapsed as the probe is continued tobe drawn back through the HAS. As probe is withdrawn, the perforatorvein or other HAS is constricted; if desired, the sequential-quadranttreatment procedure described above is employed. The procedure couldalso be performed using a single polarity and/or electrode device.Additionally, the protocol illustrated could also be used in performingan extravascular procedure.

FIG. 14 depicts another embodiment of the probe 400 that can begenerally similar to the probe 400 of FIG. 13, except as furtherdiscussed below. Instead of or in addition to the electrodes, the probe400 of FIG. 14 includes a heating element 460 at or near the distal endof the shafts 410, 420. The depicted heating element is a resistiveheating coil, but alternatively any other suitable electrically drivenheating element may be employed, or a non-electrical heating elementsuch as a fluid-conducting heat exchanger, chemical reaction chamber,etc. The injection channels 450 preferably extend through the outersheath 410 proximal of the heating element 460, but the channels mayalternatively be positioned midway along the heating element 460,passing between adjacent turns of the coil. The probe 400 of FIG. 14 isused to treat an HAS or perforator vein in the same manner as the probe400 of FIG. 13, with the exception that the heating element 460 isenergized to emit heat into the adjacent HAS wall HW after injection oftumescent fluid thereinto. In one embodiment, the probe 400 of FIG. 14is used to treat an HAS in an “indexing” fashion as described elsewhereherein. As a further alternative, the probe 400 of FIG. 14 can beemployed in a sequential-quadrant HAS treatment method as describedabove.

With reference to FIGS. 15 and 15A, in some embodiments of the probe 400of FIGS. 13-14, the ports or outermost ends 452 of the injectionchannels 450 are located on protrusions 454 which protrude outwardlyfrom the adjacent areas of the surface of the electrode 430, or whichprotrude outwardly from the adjacent areas of the sidewall of the outershaft 410 (where the channels 450 in question extend through the shaft410). The protrusions 454 encourage tissue penetration by the fluid,etc.

Delivery of the tumescent fluid, etc. is preferably at high pressure.The pressure may be dependent upon the pressure loss along the length ofthe catheter and the pressure drop at the orifice or needles. Forexample, in one embodiment, pressures may range from 100 to 1000 psi. Insome embodiments, the pressure exceeds 1000 psi. In some embodiments,the pressure applied is provided by a pump, such as a pump comprised ofHPLC columns.

Further details on the probe 400 can be found in U.S. Patent ApplicationPublication No. 2006/0030849A1, published on Feb. 9, 2006, titledMETHODS AND APPARATUS FOR COAGULATING AND/OR CONSTRICTING HOLLOWANATOMICAL STRUCTURES. The entirety of this publication is herebyincorporated by reference herein and made a part of this specification.

2) Tumescent Fluid Injected by Needles Combined with Perforator VeinTherapy

In some embodiments, as seen in FIG. 18, the perforator vein therapyprobe 400 includes one or more fluid injection needles 330. The needles330 can be generally similar in structure and function to the needles330 of FIGS. 8-10, to introduce tumescent fluid, a bulking agent, drugs,etc. into the tissue surrounding the HAS. Preferably, the needles 330are located within the probe 400 and are configured to extend beyond theprobe 400 to inject tumescent fluid into body tissue. Thus, the probe400 of FIG. 18 can be employed to treat an HAS in a similar manner asthe probe 400 of FIG. 13, with the exception that the needles 330 areemployed to inject tumescent fluid. For this portion of the treatmentprocedure, the needles are operated in a manner similar to the needles330 of FIGS. 8-10. Accordingly, the probe 400 may be connected to asource of tumescent fluid (not shown) so that the needles 330 are influid communication with the source.

In some embodiments, the needles 330 are extendable and retractablealong a generally straight path through the electrode 430 or outer shaft410, as depicted in FIGS. 16 and 16A. In these embodiments, extensionand retraction of the needles 330 can be accomplished by a manipulationof the distal electrode 432 and/or a moveable embodiment of the innershaft 420 coupled thereto, or with some other actuator shaft. Forexample axial or longitudinal movement of the electrode 432 and/or innershaft 420 may extend and/or retract the needles as depicted in FIG. 16(via ramp 426), and rotational movement may extend and/or retract theneedles as depicted in FIG. 16A (via cam 428). In other embodiments, aneedle or multiple needles may be rigidly fixed while the surroundingshaft is deflected causing the needles to penetrate the HAS wall andextend into the surrounding body tissue, as seen in FIGS. 17 and 17A.Preferably, this may be accomplished by external compression of thetissue which would also enable the needles to penetrate the HAS wallsHW.

III. Delivery of Tumescent Fluid Outside of HAS

In some embodiments, tumescent fluid is delivered from outside the HAS.In one “garden hose” technique, a large volume of tumescent fluid isintroduced to the fascial envelope along the length of the targeted bodytissue. In other embodiments, air pressure could be used to inject highpressure tumescent fluid from outside the body. In other embodiments aflexible insertion tube with a sharp distal end is inserted through theskin and guided to the desired location. In other embodiments, thetumescent fluid is delivered by a needle inserted to a location near thetargeted body tissue. Preferably, a needle or delivery tube is insertedthrough the skin to reach the targeted body tissue, and tumescent fluidis introduced when the needle or delivery tube reaches a desiredlocation. See FIGS. 19, 19 a, and 19 b. In some embodiments, the deviceinserted through the skin is extended and retracted by mechanical means.For example, a threaded hub located near the proximal end of the devicecould mate with a threaded luer that is rotated to extend and retractthe device. In some embodiments, one or more tumescent needles isincorporated into an access shaft, providing the needles with theability to access the fascial envelope.

Preferably, the tumescent fluid 99, which is depicted by the linesextending from the delivery tube 98, is introduced to the fascialenvelope, which is the space surrounding a vessel. See FIGS. 19, 19 a,and 19 b. In some embodiments, tumescent fluid 99 is introduced in onelocation relative to the HAS and then is mechanically pushed along thelength of the HAS, such as through manual compression and/or massage(i.e. massaging the tissue by hand through the patient's skin). The tubemay also be configured with a pump to introduce the tumescent fluid.

In some embodiments, a tumescent fluid delivery hole 102 is located adistance proximal relative to the tip of a needle 100 inserted withinbody tissue, as shown in FIG. 20. Preferably, the tumescent fluid 104 isreleased through the delivery hole 102 into body tissue surrounding theHAS walls 32. In other embodiments, a delivery tube 98 can be extendedthrough the delivery hole 102 to deliver tumescent fluid 104 a distancefrom the delivery hole 102. Furthermore, the delivery tube 98 may bemovable with respect to the needle 100 such that it can be extended andretracted within the fascial envelope along the length of the HAS tointroduce tumescent fluid 104 along a greater length of the HAS. Infurther embodiments, the delivery tube 98 may be configured withmultiple tumescent fluid delivery points along its length and around itsperimeter. This would allow simultaneous tumescent fluid delivery alonga greater length of the HAS. Additionally, a rod may be inserted throughthe delivery tube 98 to stiffen the delivery tube 98 during placement.

In some embodiments, impedance is used to indicate the location of thedelivery hole with respect to the HAS. This may be accomplished with asensing electrode at the distal end of the needle. Preferably, thisassists in determining whether the needle tip is inside or outside theHAS and the corresponding location of the delivery hole. For example,the needle may be pushed within the body tissue until the impedancedrops, which may indicate the delivery hole is in the desired locationto deliver tumescent fluid. In one embodiment, the delivery hole isoutside the HAS when the needle has penetrated the HAS. In oneembodiment, the steps to accomplish this include: (1) Locate the HASwith ultrasound; (2) push the needle directly down toward the HAS; (3)Achieve the proper impedance; (4) Inject the tumescent fluid; (5)Reposition the device down the vein and repeat the process. In someembodiments, aspiration and flashback as well as ultrasound imaging isused to ensure proper location.

In some embodiments, the delivery of the tumescent fluid may beaccording to the following method: Use a compression means and/orDoppler Ultrasound to identify the location of the target valve; (2)compress the target region and assess whether the reduced diameter doesindeed rectify the incompetence; (3) mark the location on the skin; (4)position a needle tip at a location which allows at least two otherplacements around the HAS at uniform spacing; (5) inject sufficientvolume of tumescent fluid to cause the region to slightly tumesce; (6)repeat the steps above in at least two other locations around the HAS.

In some embodiments, HAS therapy may be provided in combination withdelivery of tumescent fluid outside the HAS. For example, RF electrodetherapy or heating coil therapy can be used.

In some embodiments, tumescent fluid may be delivered by laying a fluidtube with needles connected on the outside of the skin along a vein. Theneedles could then be pushed toward the skin to penetrate body tissueand inject tumescent fluid.

IV. Tumescent Fluid

Any known type of tumescent fluid can be used in connection with thedisclosed apparatus and methods, such as saline or lidocaine with orwithout epinephrine. The tumescent fluid could also be a solid, gas,cold or chilled fluid, gel, or any other type of fluid. Preferably, thetumescent consists of saline and lidocaine, with or without epinephrine.The fluid primarily acts as an analgesic, but also the nature of thefluid may improve the thermal isolation or facilitate movement of thefluid along the HAS. For example, gas may be a good thermal isolator andmay travel easily along the length of the vein. Additionally, thetemperature, pressure or volume or other properties of the tumescentfluid can be varied to provide better therapy through tumescentanesthesia. For example, super chilled (or iced) tumescent fluid mayprovide a better heat sink. Additionally, viscosity additives may alterthe heat capacity. In some embodiments, a pump is used to transport thetumescent fluid to the desired location. In some embodiments, a pump isincluded that cools, mixes and monitors dosage of the tumescent fluid.The pump may be configured with an alarm that factors in the patient'sweight. In some embodiments, tumescent fluid is introduced in onelocation relative to the HAS and then is mechanically pushed along thelength of the HAS by massaging the tissue by hand through the patient'sskin. In other embodiments, the tumescent fluid is introduced in onelocation and as the volume is increase the fluid travels along andaround the fascial envelop to envelop and compress the HAS.

In addition, one or more bulking agents may be used in connection withthe disclosed apparatus and methods. A bulking agent is a relativelyinert agent, such as a bioabsorbable gel or liquid, that simply occupiesspace in or “bulks” the tissue into which the agent is injected.

V. Sterilization

Additional embodiments comprise methods of sterilization. Certain suchmethods can comprise sterilizing, either terminally or sub-terminally,any of the apparatus disclosed herein that are intended for insertioninto (or other contact with) the patient or that are intended for use ator near the surgical field during treatment of a patient. Any suitablemethod of sterilization, whether presently known or later developed, canbe employed.

Accordingly, certain methods comprise sterilizing, either terminally orsub-terminally, any one or combination of the apparatus depicted inFIGS. 1, 1A, 1B, 1C, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,15A, 16, 16A, 17, 17A, 19, 19A, 19B, or 20. Any suitable method ofsterilization, whether presently known or later developed, can beemployed. For example, the method can comprise sterilizing any of theabove-listed apparatus with an effective dose of a sterilant such ascyclodextrin (Cidex™), ethylene oxide (EtO), steam, hydrogen peroxidevapor, electron beam (E-beam), gamma irradiation, x-rays, or anycombination of these sterilants.

The sterilization methods can be performed on the apparatus in questionwhile the apparatus is partially or completely assembled (or partiallyor completely disassembled); thus, the methods can further comprisepartially or completely assembling (or partially or completelydisassembling) the apparatus before applying a dose of the selectedsterilant(s). The sterilization methods can also optionally compriseapplying one or more biological or chemical indicators to the apparatusbefore exposing the apparatus to the sterilant(s), and assessingmortality or reaction state of the indicator(s) after exposure. As afurther option, the sterilization methods can involve monitoringrelevant parameters in a sterilization chamber containing the apparatus,such as sterilant concentration, relative humidity, pressure, and/orapparatus temperature.

In view of the foregoing discussion of methods of sterilization, furtherembodiments comprise sterile apparatus. Sterile apparatus can compriseany of the apparatus disclosed herein that are intended for insertioninto (or other contact with) the patient or that are intended for use ator near the surgical field during treatment of a patient. Morespecifically, any one or combination of the apparatus depicted in FIGS.1, 1A, 1B, 1C, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 15A, 16,16A, 17, 17A, 19, 19A, 19B, or 20 can be provided as a sterileapparatus.

Except as further described herein, the embodiments, features, systems,devices, materials, methods and techniques described herein may, in someembodiments, be similar to any one or more of the embodiments, features,systems, devices, materials, methods and techniques described in U.S.Patent Application Publication No. 2006/0030849A1, published on Feb. 9,2006, titled METHODS AND APPARATUS FOR COAGULATING AND/OR CONSTRICTINGHOLLOW ANATOMICAL STRUCTURES; or in U.S. Patent Application PublicationNo. 2006/0085054A1, published on Apr. 20, 2006, titled METHODS ANDAPPARATUS FOR TREATMENT OF HOLLOW ANATOMICAL STRUCTURES; or in U.S. Pat.No. 6,769,433 issued on Aug. 3, 2004 to Zikorus et. al., titledEXPANDABLE VEIN LIGATOR CATHETER HAVING MULTIPLE ELECTRODE LEADS, ANDMETHOD; or in U.S. Pat. No. 6,752,803 issued on Jun. 22, 2004 to Goldmanet al., titled METHOD AND APPARATUS FOR APPLYING ENERGY TO BIOLOGICALTISSUE INCLUDING THE USE OF TUMESCENT TISSUE COMPRESSION; or in U.S.Provisional Application No. 60/780,948, filed Mar. 9, 2006, entitledSYSTEMS AND METHODS FOR TREATING A HOLLOW ANATOMICAL STRUCTURE. Inaddition, the embodiments, features, systems, devices, materials,methods and techniques described herein may, in certain embodiments, beapplied to or used in connection with any one or more of theembodiments, features, systems, devices, materials, methods andtechniques disclosed in the above-mentioned U.S. patents, Publicationsand provisional application. The entirety of each of these patents,publications and provisional application is hereby incorporated byreference herein and made a part of this specification.

A number of applications, publications and external documents areincorporated by reference herein. Any conflict or contradiction betweena statement in the bodily text of this specification and a statement inany of the incorporated documents is to be resolved in favor of thestatement in the bodily text.

While certain embodiments of the invention(s) have been described, theseembodiments have been presented by way of example only, and are notintended to limit the scope of the disclosure. Indeed, the novel methodsand systems described herein may be embodied in a variety of otherforms; furthermore, various omissions, substitutions and changes in theform of the methods and systems described herein may be made withoutdeparting from the scope of the disclosure.

1. A catheter for treating a hollow anatomical structure (HAS), saidcatheter comprising: one or more shafts which extend away from aproximal end of said catheter toward a distal end thereof; an HASconstriction energy source located at or near said distal end of saidcatheter; and at least one radially expandable transmural fluid deliverychannel located in said catheter near said HAS constriction energysource.
 2. The catheter of claim 1, wherein said constriction energysource comprises an electrically resistive heating element.
 3. Thecatheter of claim 2, wherein said resistive heating element comprises aresistive coil.
 4. The catheter of claim 2, wherein said resistiveheating element is located on an outer surface of one of said one ormore shafts, and said outer surface includes at least one port throughwhich said at least one fluid delivery channel is extendable.
 5. Thecatheter of claim 1, wherein said constriction energy source comprisesat least one electrode.
 6. The catheter of claim 5, wherein said one ormore catheter shafts comprises a first shaft which carries said at leastone electrode, and a second shaft which carries said at least one fluiddelivery channel.
 7. The catheter of claim 6, wherein said first andsecond shafts are coaxial.
 8. The catheter of claim 5, wherein said atleast one electrode comprises a plurality of electrodes, a firstelectrode of which is spaced longitudinally from a second electrodealong an outer surface of one of said one or more catheter shafts. 9.The catheter of claim 1, wherein said fluid delivery channel comprisesat least one needle.
 10. The catheter of claim 9, wherein said needlehas a sharp tip and a fluid delivery port at or near said tip.
 11. Thecatheter of claim 1, wherein said fluid delivery channel comprises atleast one perforating jet.
 12. The catheter of claim 1, furthercomprising a source of tumescent fluid which is in fluid communicationwith said fluid delivery channel.
 13. The catheter of claim 1, whereinsaid one or more catheter shafts comprise a plurality of shafts whichare arranged coaxially.
 14. The catheter of claim 13, wherein said firstand second shafts are coaxial.
 15. A catheter for treating a hollowanatomical structure, said catheter comprising: a shaft which extendsfrom a proximal end to a distal end thereof; a therapeutic energy sourcelocated at or near a distal end of said shaft, said therapeutic energysource comprising at least one of an electrode and a resistive heatingelement; and at least one fluid delivery channel located in said shaft,said channel having a delivery tip which is movable from a retractedposition near a longitudinal axis of said shaft, to a deployed positionfarther from said longitudinal axis.
 16. The catheter of claim 15,wherein said therapeutic energy source comprises a plurality ofelectrodes, a first electrode of which is spaced longitudinally alongsaid catheter from a second electrode.
 17. The catheter of claim 15,wherein said fluid delivery channel comprises at least one needle. 18.The catheter of claim 17, wherein said needle has a sharp tip and afluid delivery port at or near said tip.
 19. The catheter of claim 15,wherein said fluid delivery channel comprises at least one perforatingjet.
 20. The catheter of claim 15, further comprising a source oftumescent fluid which is in fluid communication with said fluid deliverychannel.
 21. A method of treating a hollow anatomical structure with acatheter having one or more shafts which extend away from a proximal endof said catheter toward a distal end thereof, said method comprising:conducting a fluid, via a fluid delivery channel of said catheter, froma location within said hollow anatomical structure and within one ofsaid shafts, to a tip of said channel which is located radially outwardfrom said one or more shafts; with a therapeutic energy source of saidcatheter system, passing energy into a wall of said hollow anatomicalstructure; and with said energy, constricting said hollow anatomicalstructure.
 22. The method of claim 21, wherein passing energy comprisesdriving RF energy through said wall of said hollow anatomical structurewith at least one electrode of said catheter.
 23. The method of claim21, wherein passing energy comprises heating said wall of said hollowanatomical structure with at least one heating element of said cathetersystem.
 24. The method of claim 21, wherein conducting said fluidcomprises conducting said fluid through said wall of said hollowanatomical structure.
 25. The method of claim 24, further comprisingpenetrating said wall of said hollow anatomical structure with saidchannel.
 26. The method of claim 21, wherein conducting said fluidcomprises conducting tumescent fluid into tissue near said hollowanatomical structure and thereby initially constricting said hollowanatomical structure.
 27. The method of claim 26, wherein passing saidenergy comprises passing said energy after said initial constriction ofsaid hollow anatomical structure.
 28. The method of claim 21, furthercomprising: after passing said energy, moving said energy source alongsaid hollow anatomical structure to a first subsequent treatmentposition, and conducting said fluid via said fluid delivery channel intotissue adjacent said hollow anatomical structure near said firstsubsequent treatment position.
 29. The method of claim 28, furthercomprising passing said energy while said energy source is at said firstsubsequent treatment position.
 30. A catheter for treating a hollowanatomical structure, said catheter comprising: a shaft which extendsfrom a proximal end to a distal end thereof; a therapeutic energy sourcelocated at or near a distal end of said shaft, said therapeutic energysource forming an energy coupling surface which faces generally radiallyoutward from said shaft; at least one fluid delivery channel whichextends in a generally radial direction through at least one of saidenergy source and a sidewall of said shaft; said fluid delivery channelhaving an outer endpoint positioned in a locally radially outermostregion of said energy source or said shaft.
 31. The catheter of claim30, wherein said energy coupling surface is fixed relative to saidshaft.
 32. The catheter of claim 30, wherein said fluid delivery channelextends through said energy source.
 33. The catheter of claim 30,wherein said energy source is an electrode.
 34. The catheter of claim30, wherein said energy source is a heat emitting element.
 35. Thecatheter of claim 34, wherein said heat emitting element is anelectrically resistive heater.
 36. The catheter of claim 34, whereinsaid heat emitting element is a heating coil.
 37. The catheter of claim36, wherein said fluid delivery channel extends through said heatingcoil.